Plum 360 infusion system receives 510 (k) approval at FDA- Hospira
Hospira, Inc. has announced that the company has received 510(k) regulatory clearance from the FDA for the Plum 360 infusion system with Hospira MedNet safety software. The newest in Hospira's portfolio of infusion devices, the Plum 360 system builds on the unique air management and secondary delivery features of Plum A+, while expanding its drug library and wireless capability to enable streamlined electronic medical record (EMR) integration.
Comment: The Plum 360 is one of a new generation of infusion pumps at Hospira, following on the Plum A+ pump and the Sapphire ambulatory device, which the company has licensed from Q Core Medical. These devices replace the Symbiq infusion device, which the FDA banned from importation in November 2012, and its GemStar ambulatory pump, the subject of a Class I recall in 2013.